Get Your Aseptic Facility Ready For EU GMP Annex 1

This live panel discussion, “Get your aseptic facility ready for EU GMP Annex 1,” is part of a webinar regulatory series, “Let's Talk - Regulatory know-how for Pharma Manufacturing & Quality Control,” organized by MilliporeSigma to leverage important considerations to consider for your process to meet new regulations.

In line with the contamination control strategy (CCS), the selection of environmental monitoring (EM) sampling sites and methods is crucial for a GMP environment. Here, we review CCS considerations, the setup and application of a microbiological EM program, and how to optimize the design of hardware and consumables for specific environments.